Infinity M300 Supplement Telemetry Unit SW VG2.4 Instructions for Use Sept 2020

Contents

Contents Contents...

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Information about this document...

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Typographical conventions...

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ECG, arrhythmia, and ST segment monitoring with M300... 41 Known issues... 44

Infinity M300 VG2.4...

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Reprocessing...

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Infinity M300 Device description...

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Safety Information... Information on reprocessing... Classification for reprocessing... Before reprocessing... Validated reprocessing procedures... Cleaning... Surface disinfection... Other agents and reprocessing procedures . . Reprocessing of patient-specific accessories . Cleaning... Surface disinfection... Other agents and reprocessing procedures . . After reprocessing...

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Indications for use/Intended use...

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Contraindication...

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For your safety and that of your patients. . . 10 Mandatory reporting of adverse events... 10 General safety information... 10 Environment of Use... 11 Patient Population... 12 Open-source software... 12 Network security information and recommendations... 12 Device symbols... 16

Additional information...

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Infinity M300 Features for VG2.4... 17 QRS Threshold... 17 M300 Arrhythmia processing... 19 ECG signal processing and display... 20 Patient preparation for ECG monitoring... 20 ECG precautions... 21 ICS Telemetry defaults screen... 22 M300 Demographic screens... 23 Alarm settings... 24 Technical specifications... 25 M300 Performance data... 29 M300 accessories overview... 30 Pulse Oximetry (SpO2) monitoring with Masimo (for M300)... 30 Electromagnetic compatibility (EMC)... 33 EMC third edition... 33 EMC fourth edition... 38

Supplement – Infinity® M300 – VG2.4

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Supplement – Infinity® M300 – VG2.4

Information about this document

Information about this document

Typographical conventions 1

Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each new sequence of actions.



Bullet points indicate individual actions or different options for action.

–

Dashes indicate the listing of data, options, or objects.

(A) Letters in parentheses refer to elements in the related illustration. A Letters in illustrations denote elements referred to in the text.

Trademarks

Trademarks owned by Dräger Trademark Infinity® MCable® MonoLead®

The following web page provides a list of the countries in which the trademarks are registered: https://www.draeger.com/trademarks

Supplement – Infinity® M300 – VG2.4

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Information about this document

Trademarks owned by third-party manufacturers Trademark

Trademark owner

rainbow

Masimo Corporation.

®

Masimo

®

Masimo® SET® (Signal Extraction Technology) Medtronic

Capnoline® Microstream

®

TOFscan®

IDMED

Definitions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the equipment or other property. NOTE A NOTE provides additional information intended to avoid inconveniences during operation.

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Supplement – Infinity® M300 – VG2.4

Infinity M300 VG2.4

Infinity M300 VG2.4 This supplement contains the VG2.4 instructions for use for the Infinity M300. The IFU that ships with this supplement is the Infinity CentralStation Wide SW VG 1.n and Infinity M300.

Infinity M300 Device description The Infinity M300 is a wireless telemetry, patient-worn device with rechargeable lithium-ion battery which monitors ECG and SpO2 physiological data, features a color display, and local alarm alerts and keypad interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis. SpO2 functions include pulse plethysmogram and pulse rate. Infinity M300 with TruST allows for 12-lead ECG monitoring with a reduced set of electrodes by deriving values for missing leads.

Infinity M300 components The standard Infinity M300 includes the following:  Infinity M300 patient-worn device  Infinity M300 Bedside Charger  Infinity M300 CentralCharger  Infinity M300 programming kit

Infinity M300 communications Infinity M300 connects to the Infinity network via 802.11 wireless communication with hospital access points (AP). From the AP, data is routed over the Infinity network via wired Ethernet for real-time display and annunciation at the Infinity CentralStation Wide (Widescreen) central monitoring workstation. The Infinity CentralStation (ICS) Wide allows for simultaneous central monitoring of up to thirty-two (32) Infinity M300 devices to support wireless telemetry monitoring.

Infinity M300 user interfaces and functions The Infinity M300 communicates bilaterally with the Infinity CentralStation (ICS) which serves as the primary display, user interface and alarm annunciator for acquired M300 physiological patient data. The Infinity M300 6-button local keypad and display serves as a secondary user interface for clinicians to access local features and functions.

Supplement – Infinity® M300 – VG2.4

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Infinity M300 VG2.4

To facilitate patient mobility the M300 can be placed in a disposable or re-usable shower pouch and worn by the patient. When a patient is sedentary (in bed or sitting) the clinician can place the Infinity M300 in the Bedside Charger to provide a slow charge for the device. When the Infinity M300 is not in clinical use, it may be stored and recharged at an accelerated rate in the CentralCharger. At the ICS clinicians perform the following functions:  Admit / Discharge patients  Initiate / Discontinue M300 Standby  Enter patient demographics  Assign patient categories  Assign alarm limits  Manage M300 audio pause, alarm pause, alarm silence  Access patient alarm history  Access patient full disclosure records At the Infinity M300 clinicians perform the following functions:  Turn device on and off  Adjust alarm volume  Manage alarm pause  Scroll through waveforms  Discharge patients  Initiate strip recordings  Issue staff alerts

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Supplement – Infinity® M300 – VG2.4

Indications for use/Intended use

Indications for use/Intended use The Infinity M300 is intended for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network. The Infinity M300 with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

Contraindication The Infinity M300 is not compatible for use in an MRI magnetic field.

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For your safety and that of your patients

For your safety and that of your patients

Mandatory reporting of adverse events Serious adverse events with this product must be reported to Dräger and the responsible authorities.

General safety information The following WARNING and CAUTION statements apply to general operation of the medical device.

Warnings: WARNING To properly use the M300 medical device, read and comply with the latest instructions for use and this supplement. WARNING Inaccurate SpO2 measurements may result under the following conditions: – Elevated levels of methemoglobin – Elevated levels of total bilirubin – Excessive patient motion – Severe anemia – Low arterial perfusion WARNING Risk of electric shock and device malfunction. Penetrating liquid may cause the following: – Damage to the device – Electric shock – Device malfunctions Ensure that no liquid penetrates the device. WARNING Do not immerse or rinse the device and its peripherals. If you spill liquid on the device (including the battery or accessories), or accidentally immerse it in liquid, allow contacts to thoroughly dry.

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Supplement – Infinity® M300 – VG2.4

For your safety and that of your patients

Cautions: CAUTION Signs of wear, such as cracks, deformation, discoloration, or peeling, may occur with reprocessed products. Check the products for signs of wear and replace them if necessary. CAUTION To avoid damaging the device, do not use sharp tools or abrasives. Never immerse electrical connectors in water or other liquids. CAUTION Do not autoclave accessories.

Environment of Use The Infinity M300 is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

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For your safety and that of your patients

Patient Population The Infinity M300 is intended for use with ambulatory and non-ambulatory adult and pediatric patients, (one patient at a time) excluding infants and neonates, in environments where patient care is provided by healthcare professionals. NOTE Clinical judgment must be used to determine when the M300 should be used on a specific pediatric patient. Assigning a specific weight or age to ECG performance is not practical as there are multiple factors to be considered when making a determination for patient care.

Open-source software Dräger devices that use software may use open-source software, depending on their setup. Open-source software may be subject to different terms of license. Additional information regarding the open-source software used in this device is available at the following web page: https://www.draeger.com/en_me/Hospital/Online-Services/Open-Source

Network security information and recommendations Dräger provides the following security information and recommendations:  Dräger recommends always following network security best practices, such as maintaining software, segmenting via firewalls, closing unused ports, restricting user permissions, limiting third party access, and monitoring network activity.  M300 device settings may be compromised in the event of a cybersecurity attack or other configuration error. To restore device settings to their previous state, power cycle the unit and select NO when prompted on the New Patient screen. Device settings can be restored manually with patient discharge and re-admit at the M300. In the event of a cybersecurity attack, if the device enters a fail state (sustained alarm tone sound), power cycle the unit. If a device experiences multiple resets and/or fail state behavior, assign each patient to a bedside monitor, isolate the affected devices and immediately contact your hospital’s biomedical department and IT department for support. Do not place devices back into service until the situation is resolved.  Dräger recommends the use of WPA2-Enterprise/EAP-TLS to provide for strong authentication and data protection for wireless communication between M300 and 802.11 access points. With this protection in place, clinical data will be secure in a wireless encrypted tunnel. Customers configuring wireless infrastructures with WPA or WPA+WPA2 will cause the M300 to use the deprecated TKIP cipher which may compromise security. Dräger recommends configuring the network infrastructure to use WPA2 only. 12

Supplement – Infinity® M300 – VG2.4

For your safety and that of your patients

 Dräger recommends that the responsible organization install and operate Infinity monitoring devices on separate, isolated, VLANs to reduce risk from network security vulnerabilities. Use of QoS with M300 is required to ensure optimal network data transmission. Without these measures there is an increased risk that critical events may go undetected in cases of malicious attack, which could result in patient harm.  Dräger maintains a product security page for continued visibility into cybersecurity threats in the field and possible vulnerabilities in our devices. In the event you encounter a cybersecurity threat or identify a security vulnerability in one of our products, visit the following website to find instructions on how to provide this information to Dräger via encrypted e-mail: https://static.draeger.com/security/.  The M300 device provides logging of software resets and presence of multicast. M300 error logs may be obtained using the device webpage or via connection to a serial programming cable and appropriate terminal software. If errors are observed, report the condition to the hospital's Biomed and IT departments.  To maintain the M300 logs for investigatory purposes, isolate the affected M300 unit(s), place the devices in a bedside charger, and contact Dräger service personnel for support and troubleshooting. Do not place the M300 in the CentralCharger as this will discharge the patient deleting useful data.  The device configurations can be recovered by one of the following methods: –

Programming cable with password

–

Manually discharge patient, re-admit and configure settings

–

Manually configure settings at the M300

 The M300 device contains the following interfaces: Type

Purpose

Display

Visualize various clinical parameters and device configuration settings

Keypad

Provide for modest level of user interaction, such as startup/shutdown of device; alarm silence; and local discharge

Wireless Network

Provides for communication with other Infinity network devices and some diagnostic tools via 802.11

Serial Console

Provides access to service menu to allow for configuration and maintenance of device

The M300 device communicates via the 802.11 wireless LAN standard. Client ports are used outbound from the device, while server ports accept incoming connections inbound from other devices on the network: Application Protocol

Transport Protocol

Port Number

Client/Server

FTP

TCP

21

Server

HTTP

TCP

80

Server

Infinity ACS

TCP

1950

Server

Infinity PDS

TCP

2050

Client

Infinity NameService

TCP

2150

Client

Supplement – Infinity® M300 – VG2.4

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For your safety and that of your patients

Application Protocol

Transport Protocol

Port Number

Client/Server

Infinity Recorder

TCP

6000

Client

Infinity Recorder

TCP

6050

Client

Infinity RemoteRecord

TCP

7100

Server

Infinity LocalDischarge

TCP

9200

Client

Infinity LLIP

TCP

18000

Client

 In the presence of multicast network traffic, ‘Network Config Error’ will be annunciated on the M300 display and will be captured in the error log. M300 error logs may be obtained using the device webpage or via connection to a serial programming cable and appropriate terminal software. If this error is observed, report the condition to the hospital's Biomed and IT departments. If a device experiences multiple resets the unit may enter a fail state and issue a sustained audible alarm. If your facility experiences multiple M300 device resets and/or fail state behavior, assign each patient to a bedside monitor, isolate the affected devices and immediately contact your hospital’s biomedical department and IT department for support. Do not place devices back into service until the situation is resolved.  To enhance network and device security, restrict physical access to the Infinity network, monitoring devices and accessories to hospital personnel according to job function and classification. Restrict physical access to unused ethernet ports, and unused USB and serial ports.  Modifications to the Infinity network after initial installation could result in degraded performance and/or security risks. Contact Dräger Service personnel to ensure optimal network performance for any planned network modification. Unauthorized modifications to network settings could degrade network performance and could result in patient harm due to delayed assessment or intervention. NOTE M300 is an embedded code device that verifies sensitive data integrity (i.e., code space, stored configuration data, and DRAM content) at startup and during operation. If the stored settings are corrupt, the device assumes that DRAM has failed and restores its factory default settings with audible and visual notification to users.

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Supplement – Infinity® M300 – VG2.4

For your safety and that of your patients

Infinity Network Diagram Example Configuration

      




 


  

 




  



























 

 
















 
 










M300 message The following message may display on the M300: Priority

Message

Description

None

Network config error

Multicast traffic is detected Contact your hospital on the VLAN. biomedical department and IT department for support.

Supplement – Infinity® M300 – VG2.4

Action

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For your safety and that of your patients

Device symbols The following table lists the new hardware device symbols displayed on various Dräger hardware. Symbol

Description Do not re-use, single patient use

Do not re-use Not made with natural rubber latex

Not made with natural rubber latex

Not made with natural rubber latex

Medical Device

For USA: Rx only

Caution: Federal law restricts this device to sale by or on the order of a physician.

Refer to the IFU, Infinity CentralStation Wide SW VG 1.n and Infinity M300, that ships with this supplement for additional device symbols.

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Supplement – Infinity® M300 – VG2.4

Infinity M300 Features for VG2.4

Infinity M300 Features for VG2.4 This section contains the Infinity M300 features for the VG2.4 release.

QRS Threshold Depending on the software versions running on the ICS and the M300 devices, the procedure you follow to set the QRS threshold on the M300 will differ:  If ICS is VG2.1.1 or later, and the M300 is VG 2.4 or later, you set the QRS threshold by a menu selection, either Normal or Low  If ICS is VG2.1 or earlier, or the M300 is VG2.3 or earlier, the QRS threshold is linked to the ECG gain and the QRS threshold buttons are greyed out. The following relationships apply: –

Setting the gain to 1, 2, 4, or 8 mV/cm, automatically sets to the QRS threshold to Normal.

–

Setting the gain to 0.5 or 0.25 mV/cm, automatically sets the QRS threshold to Low.

NOTE Patient admitted on M300 VG2.4: Changes to QRS/ARR processing leads and gain settings do not change QRS threshold settings. Patient admitted on M300 VG2.3 and earlier: – Changes to QRS/ARR processing leads and gain settings will alter the QRS threshold settings between Normal and Low. – When selecting one or two QRS/ARR processing leads, a gain setting of < 1mv on either lead, sets the ICS QRS threshold to Low. – When selecting one or two QRS/ARR processing leads, a gain setting of > 1mv on all leads, sets the ICS QRS threshold to Normal.

To set the QRS Threshold using ICS VG2.1.1 and M300 VG2.4 From the Main ICS screen: 1

Click System setup on the ICS.

2

Click Layouts.

3

Click one of the following: –

Normal to detect QRS complexes of normal amplitude.

–

Low to detect QRS complexes of low amplitude.

Supplement – Infinity® M300 – VG2.4

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Infinity M300 Features for VG2.4

To set the QRS Threshold using earlier ICS and M300 versions For ICS 2.1 or earlier, or M300 VG2.3 or earlier, from the Main ICS screen: 1

Click System setup on the ICS.

2

Click Layouts.

3

Click the dropdown arrow of the appropriate Gain/Scale channel.

4

Select the appropriate Gain value: –

Select a value of 1,2,4 or 8 mV/cm to set the QRS threshold to Normal.

–

Select a value of 0.5 or 0.25 mV/cm to set the QRS threshold to Low.

QRS detection amplitude QRS detection amplitude: 0.5 to 5.0 mVp-v RTI QRS threshold detection duration: Adult: 70 to 120 ms Pediatric: 40 to 120 ms Configuring the QRS threshold to Low may extend the QRS detection amplitude to as low as 0.17 mVp-v RTI. WARNING Risk of inaccurate HR value. If the QRS setting is set to Low in the presence of HR artifact, the associated HR value may be inaccurate. To avoid an inaccurate HR value, it is recommended to set the QRS threshold setting to Normal.

ECG QRS processing settings Gain/Scale column

mV/cm

Detection threshold

For all ECG waveforms: 0.25, 0.5, 1 (default), 2, 4, 8 mV/cm

8

>0.35 mV

4

>0.35 mV

The M300 uses an AAMI-compliant regular QRS threshold when you select a scale of 1, 2, 4, or 8 mV/cm. If you select a scale of 0.25 or 0.5 mV/cm, the M300 lowers the detection threshold, and the AAMI requirement is not met.

2

>0.35 mV

1

>0.35 mV

0.5

>0.17 mV

0.25

>0.17 mV

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Supplement – Infinity® M300 – VG2.4

Infinity M300 Features for VG2.4

M300 Arrhythmia processing Arrhythmias are identified using an internal detection process. This process does the following: –

Filters out ECG signal artifacts

–

Detects the beat pattern

–

Classifies the beat pattern

–

Detects the rhythm

When arrhythmia analysis is enabled, multiple alarm conditions may occur simultaneously. Announcing all the alarm conditions would cause alarm fatigue and prevent the clinician from addressing the most serious condition. For this reason, the arrhythmia conditions are prioritized and only the highest priority alarm event shall annunciate. The priority order of the arrhythmia events is based on the default priority defined in the algorithm and the alarm grade configured by the user. Based on this detection process, arrhythmias and other associated events are reported in the following order of severity: 1

ASY (asystole)

2

VF (ventricular fibrillation)

3

VTACH (ventricular tachycardia)

4

RUN (ventricular run)

5

AIVR (accelerated idioventricular rhythm)

6

SVT (supraventricular tachycardia)

7

CPT (ventricular couplet)

8

BGM (bigeminy)

9

TACH (tachycardia)

10 Brady (bradycardia) 11 Pause (sinus pause) 12 ARR artifact In addition to storage as events, the two high priority alarms, ASY and VF, are also stored and displayed in the trends of the ICS. An arrhythmia with a high grade alarm configuration has a higher priority than an arrhythmia with a medium, low or disabled alarm grade configuration. An arrhythmia with a medium grade alarm configuration has a higher priority than an arrhythmia with a low or disabled alarm grade configuration. An arrhythmia with a low grade alarm configuration has a higher priority than an arrhythmia with a disabled alarm configuration. The priority for arrhythmia events configured with the same alarm grade follows the arrhythmia hierarchy list. When arrhythmia artifact is present (ARTF) at 100% artifact level, no arrhythmia events are recognized except for bradycardia and ventricular fibrillation. If sinus tachycardia and ventricular tachycardia are configured at the same alarm grade, a ventricular tachycardia will take priority if the rate is high enough and the beats are classified as ventricular beats.

Supplement – Infinity® M300 – VG2.4

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Infinity M300 Features for VG2.4

ECG signal processing and display The M300 calculates heart rates within a range of 15 beats to 300 beats per minute, using the R-R intervals of the last 10 seconds. This calculation excludes the two longest and two shortest R-R intervals. The M300 averages the remaining intervals and displays the result as the current heart rate in the heart rate parameter box. During dual-channel processing, a weight is assigned to each channel depending on its level of artifact. The channel with less artifact always receives the greater weight. When a channel exceeds a certain level of artifact, it is excluded from the composite signal, and the M300 shifts to single-channel processing. If both channels experience excessive artifact, the message ECG artifact appears until at least one channel is sufficiently free of artifact. During artifact, asterisks (* * *) replace the heart rate value. When the artifact clears, QRS processing resumes without initiating a relearning phase. NOTE For heart rates of 300 bpm and greater, the monitor may display VF and not the expected +++ as the parameter value.

Patient preparation for ECG monitoring The following tips provide optimal ECG monitoring results but must never replace hospital-approved practices or the recommendations of the electrode manufacturer. Follow hospital procedures for proper skin preparation. Dräger recommends Ag/AgCl disposable electrodes. Never use disposable electrodes after their expiration date and make sure that there is enough gel and that the gel has not dried out. If QRS detection threshold is configured to Low, P- and T-waves with amplitudes exceeding 0.17 mV may be interpreted as QRS complexes. P- and T-waves with amplitudes exceeding 0.35 mV when QRS detection threshold is configured to Normal, may be interpreted as QRS complexes. The algorithm has implemented safeguards to reduce the occurrence of P- and T-wave detection as QRS complexes, however additional steps can be taken to prevent and/or troubleshoot occurrence: –

To allow detection of low heart rate conditions under these circumstances, place the lead with the highest R-wave in ECG Channel number 1.

–

If P- and T-waves are misinterpreted, confirm that the lead with highest R-wave is in ECG Channel number 1 and set QRS detection threshold to Normal.

–

If P- and T-waves continue to be misinterpreted, reposition the electrodes or use a pulse oximeter to monitor the pulse rate.

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Supplement – Infinity® M300 – VG2.4

Infinity M300 Features for VG2.4

To maintain a clear signal, change electrodes every 24 to 48 hours or more often when the following occurs: –

ECG signal degradation

–

Excessive patient perspiration

–

Skin irritation

Consider the following when selecting electrode sites: –

Surgery – keep electrodes as far from the surgical site as possible, while maintaining a clinically useful lead configuration.

–

Burn patients – use sterile electrodes. Clean the equipment thoroughly and follow hospital infection control procedures.

ECG precautions WARNING Do not rely solely on the ECG when monitoring seizure-prone patients. Electrical artifacts of noncardiac origin, such as seizure, may prevent detection of certain arrhythmias.

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